Efficacy of Amine Fluoride/Stannous Fluoride Mouthrinses on the Reduction of Plaque and Gingival Inflammation

Aim: To evaluate the efficacy of an experimental amine fluoride/stannous fluoride mouthrinse on plaque during home-use. A secondary outcome is to investigate the efficacy on gingivitis and staining potential. Material and Methods: For this three-month randomized, investigator-blinded and clinically controlled study in parallel groups, 240 adult participants with gingivitis were recruited. The test group (n=80) rinsed with the experimental product for 30s twice daily. The positive control group (n=80) rinsed with meridol® (amine fluoride/stannous fluoride) in the same manner. In both rinsing groups habitual toothbrushing was performed. The negative control (n=80) performed toothbrushing only. Plaque index (Silness & Löe 1964), gingival index (Löe 1967), discoloration index (Brecx et al. 1993) and safety were recorded at screening, baseline, after 3 and 12 weeks. ANOVA and Bonferroni adjusted post-hoc tests at a significance level of α=0.05 were applied. Results: Both mouthrinses led to a statistically significant plaque reduction compared to the negative control after 3 and 12 weeks. However, no differences existed between test and positive control. A statistically significant gingivitis reduction was observed between test and negative control groups after 3 weeks. Tooth discoloration occurred in all groups but was higher in the rinsing groups. No difference existed between test and positive control. Conclusion: Rinsing with amine fluoride/stannous fluoride formulations in addition to toothbrushing inhibits plaque in comparison to brushing alone. With exception of gingivitis reduction up to three weeks, no further advantage of the test rinse compared to the positive control rinse was found. Keywords: plaque, gingivitis, mouthrinse, amine fluoride/stannous fluoride